This section is intended to introduce the reader to various aspects of the art that may be related to various aspects of the present invention. The following discussion is intended to provide information to facilitate a better understanding of the present invention. Accordingly, it should be understood that statements in the following discussion are to be read in this light, and not as admissions of prior art.
Disease processes have been hard to diagnose. The problem in their diagnosis is not the ability to detect that there is a disease process, but which disease process is causing the symptoms. This is likely because these processes are contained to a certain area and we have little information to diagnose them without a sample of the tissue affected. There are a variety of techniques available that try to undertake this process of diagnosis. However, these techniques are limited by their ability to only locate the site affected.
Only an invasive test, such as a myocardial biopsy, which is done after the diagnosis is hypothesized by visualizing the disease process can offer an absolute answer. We, however, are still limited in the use of this specific tissue diagnosis since we are not able to visualize the disease site affected while sampling that site leading to a poor sensitivity of taking these samples. There are areas accessible via a lumen that needs to be accessed to evaluate an area of interest. These areas of interest, specifically in the body, may also need to be sampled.
Currently, there is a technique available to invasively detect atherosclerosis. This technique employs a radiodetector on the tip of a catheter which detects metabolic activity by the use of a radiotracer. This has the greatest benefit for angiography in decision making for intervention.
However, decision making for non atherosclerotic myocardial pathologies is more problematic. After an array of non-invasive strategies to increase the pre-test probability of diagnosing these disease processes we are still left with relatively blind invasive techniques such as a myocardial biopsy as a diagnostic strategy. A variety of limitations to this blind invasive strategy are 1) the heterogeneity of the underlying pathology, 2) sampling bias/error, 3) operator limitation, and 4) need for multiple myocardial biopsies due to the above limitations.
Thus, a technique that could combine the existing radiotracer techniques with a myocardial bioptome to improve the precision of myocardial sampling too would potentially markedly decrease the number of samples, morbidity, and mortality while improving the diagnostic accuracy.
Currently, there is a technique that allows uptake of radiolabeled particles, in this case glucose into cells, and allows a catheter that detects these particles.
Patent: EP1220691
Title: Methods and apparatus for characterizing lesions in blood vessels and other body lumens. The patent involves characterizing lesions and other target sites within body lumens. It relies on introducing a radiolabeled marker that localizes to the lesion, or site of interest. The marker is then quantified by the introduction of a detector into a body lumen. This patent only allows location and characterization of the lesion of interest however it does not allow sampling to provide a definitive diagnosis.
The present invention relies on using a labeled marker, specifically a radiolabeled tracer, to localize the area(s) of interest. The marker would be administered systemically into the blood stream through the subject's vasculature. The uptake of the marker would be measured by the detector to localize the area of interest. A catheter which would be equipped with a detector and a bioptome would enable access to the area of interest. The catheter would be attached to a processor which would provide readout of the area of interest in order to provide appropriate localization of the site.